The ICALIC 2 International Multicentric Study (ICALIC2)

Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter in Canopy and Face Mask Modes for Energy Expenditure Measurement: The ICALIC 2 International Multicentric Study (Second Phase)

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

Study Overview

• Status: Terminated
• Conditions: Cancer; Hemodialysis; Surgery
• Intervention / Treatment: Device: Q-NRG®

Detailed Description

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Switzerland
  • Geneva 14
    • Geneva, Geneva 14, Switzerland, 1211
      • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis.

Description

Inclusion Criteria:

All spontaneously breathing adult patients (≥ 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.

Exclusion Criteria:

1. < 18 years
2. Intolerance or phobia to canopy or face mask
3. Physical agitation or activity (< 1hr before EE measurement)
4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed to perform EE measurement.	Time needed to perform EE will be calculated from the time the Q-NRG® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ≤10%.	Immediately after the measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy and precision of VO2, VCO2, RQ and EE measurements.	Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.	Immediately after the measurement.
Coefficient of variation of VO2, VCO2, RQ and EE.	The stability of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.	Immediately after the measurement.
Clinical condition restriction.	Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.	Immediately after the measurement.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of O2 and CO2 analysis.	Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.	Immediately after the measurement.

Collaborators and Investigators

• Sponsor: Prof. Claude Pichard

Publications and helpful links

General Publications

• Dupertuis YM, Delsoglio M, Hamilton-James K, Berger MM, Pichard C, Collet TH, Genton L. Clinical evaluation of the new indirect calorimeter in canopy and face mask mode for energy expenditure measurement in spontaneously breathing patients. Clin Nutr. 2022 Jul;41(7):1591-1599. doi: 10.1016/j.clnu.2022.05.018. Epub 2022 May 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2019
• Primary Completion (ACTUAL): June 2, 2021
• Study Completion (ACTUAL): June 2, 2021

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Energy expenditure; VO2; Indirect calorimetry; VCO2
• Other Study ID Numbers: 2019-00106 (OTHER: Ethical review agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No